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Myocardial InfarctionPhase 4NCT00356044

Arterial Access for Coronary Intervention in Myocardial Infarction

A Phase 4 study testing Coronary angioplasty in people with Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary, run by Hospital Juan Canalejo at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Coronary angioplasty
Type of treatment
Surgery or procedure
How many people
439 participants
Where
3 sitesSpain
Study dates
May 2004to Dec 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with ST elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms.

Who cannot join

  • Patients in cardiogenic shock were excluded following operator criteria.
  • Previous coronary surgery with mammary artery graft
  • Coronary artery intervention in the previous month
  • Absolute or relative contraindication for access via the radial artery route:Radial pulse absent or weak, abnormal Allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine >3 mg/dl).
  • Patients with absolute or relative contraindication for the use of the femoral route.
  • Absence of informed consent from the patient

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Juan Canalejo

    A Coruña, A Coruña, 15006

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Hospital do Meixoeiro

    Vigo, Pontevedra, 36200

Other trials in Spain

About this study

Official title: Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction

The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security.

Read the detailed description

Some groups have previously used the radial artery as the access route in the procedures of percutaneous coronary revascularization, with good results. The advantages of the radial compared with femoral access are related to a lower incidence of vascular complications. The radial access has also inconveniences such as a less predictable anatomy which can make the procedure difficult and prolong the time required.The patients with ST elevation myocardial infarction have an increased risk of vascular complications after interventional procedures because previous antithrombotic or thrombolytic therapy.On the other hand, the time and success of the procedure are significant prognostic issues.In this sitting, the radial approach might reduce vascular complications and increase other cardiovascular events when comparing with the classical femoral access. For this reason, the purpose of the study is to compare both arterial access in terms of efficacy and security and to quantify the consequences of the advantages and drawbacks of both.

Being tested
Coronary angioplasty
Keywords
Transradial access, Femoral access, Femoral vs radial access
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary angioplastyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality at 30 days

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

  2. New ST elevation acute myocardial infarction at 30 days

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

  3. Coronary revascularization as a result of recurrent ischemia at 30 days

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

  4. Major vascular complications at 30 days.

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

Secondary outcomes (6)

  1. Embolic stroke at 30 days

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

  2. Coronary revascularization at 30 days

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

  3. Cardiovascular mortality at 30 days

    Measured: within the first 30 days (plus or minus 5 days) after the index myocardial infarction

  4. Procedural time

  5. Hospital stay

  6. Estimation of costs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2006 (estimated)
  2. Study startMay 2004
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356044
Sponsor's protocol ID
CEICG 2004/063
Status last verified
Jul 2007
First submitted
24 Jul 2006
Last updated
11 Jul 2007
Results posted
No
Data monitoring committee
No

Publications

  • Saito S, Tanaka S, Hiroe Y, Miyashita Y, Takahashi S, Tanaka K, Satake S. Comparative study on transradial approach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction: results of the test for myocardial infarction by prospective unicenter randomization for access sites (TEMPURA) trial. Catheter Cardiovasc Interv. 2003 May;59(1):26-33. doi: 10.1002/ccd.10493.

    PubMed 12720237

  • Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J. 2004 Jan;147(1):31-4. doi: 10.1016/j.ahj.2003.07.019.

    PubMed 14691415

  • Vazquez Rodriguez JM, Calvino Santos R, Baz Alonso JA, Trillo Nouche R, Salgado Fernandez J, Sanmartin Fernandez M, et al. Radial vs. Femoral access in emergent coronary interventions for acute myocerdial infarction with ST segment elevation (abstract). Innovation in Intervention: i2 Summit 2007 Abstract Sessions. 10.1016/j.jacc.2007.01.048. J Am Coll Cardiol 2007;49(9_Suppl_B):12B.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronary angioplasty in people with Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary, run by Hospital Juan Canalejo at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality at 30 days (time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356044, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2007.

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